Expanded Access Data Supported Lutathera Approval, US FDA Notes
Amid broader debate on right-to-try legislation, review experience of Novartis' oncologic highlights US FDA's argument that expanded access can at least in part contribute to approval of a drug.
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US FDA Expanded Access Pilot Launching Soon With Staffing Questions Unanswered
New call center is designed to help physicians navigate the expanded access pathway for oncology products, but FDA officials are unsure about how much interest it will generate.
Platform Trials Could Be A Solution To Expanded Access, Woodcock Says
US FDA will continue expanded access activities as government shutdown continues, but CDER Director Woodcock says that platform trials can help eliminate the need for expanded access to exist.
Gottlieb's "Right To Try" Sentiment: Law Fails To Address Difficulties Faced By Drugmakers
US FDA Commissioner suggests Congress may need to explore incentives for drugmakers to make investigational products available in the pre-approval phase.